Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. 

Use additional sheet(s) if necessary.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

6b. I agree to satisfy Generic Data

Requirements as indicated on the 

attached form entitled 

"Requirements Status and 

Registrant's Response."

7a. My product is an MUP and I 

agree to satisfy the MUP 

requirement on the attached form

entitled "Requirements Status and

Registrant's Response."

7b. My product is an EUP and I 

agree to satisfy the EUP 

requirement on the attached form 

entitled "Requirements Status and 

Registrant's Response."

OMB Approval 2070-0174

1. Company Name and Address

 

N/A - Bifenthrin

Chemical # and Name: 128825

Bifenthrin

12-Jan-2012

GENERIC

ID # GDCI-128825-902

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page of 1 1

8. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Initial to indicate certification as to information on this page (full text of certification is on page one) 

13. Phone Number

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

12. Name of Company

11. Date

OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

 

Environmental Fate Data Requirements (Conventional 

Chemical)

835.1230

835.2120

835.2240

835.4100

835.4200

835.4300

835.4400

835.6100

835.6200

Sediment and soil absorption/desorption for parent 

and degradates

Hydrolysis of parent and degradates as a function of 

pH at 25 C

Direct photolysis rate of parent and degradates in 

water

Aerobic soil metabolism

Anaerobic soil metabolism

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Terrestrial field dissipation

Aquatic field dissipation

N/A - Bifenthrin

Chemical # and Name: 128825

Bifenthrin

12-Jan-2012

GENERIC

ID # GDCI-128825-902

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI

TGAI

12

12

12

24

24

24

24

12

12

Page 1 of 

(37)

(32)

(11)

(7)

(7)

(6, 9, 14)

(6, 9, 15)

N

N

N

N

N

N

N

N

N

5
OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

 

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Residue Chemistry Data Requirements for Food Uses 

(Conventional Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.4400

850.5400

860.1340

850.1010

Terrestrial Plant Toxicity (Seedling Emergence)

Terrestrial plant toxicity, Tier 1 (vegetative vigor)

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

Algal toxicity, Tiers 1 and II

Residue analytical method

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

N/A - Bifenthrin

Chemical # and Name: 128825

Bifenthrin

12-Jan-2012

GENERIC

ID # GDCI-128825-902

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

TEP

TEP

TGAI

TGAI

Residue of Concern

TGAI

12

12

12

12

24

12

Page 2 of 

(13, 20, 39)

(12, 20, 39)

(6, 23, 38)

(6, 22, 38)

(33)

(16, 19, 36)

N

N

N

N

N

Y

5
OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

 

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.1035

850.1350

850.1400

850.1500

850.2100

870.1300

870.3250

870.3465

Mysid acute toxicity test

Mysid chronic toxicity test

Fish early-life stage toxicity test

Fish life cycle toxicity

Avian acute oral toxicity test

Acute inhalation toxicity

90-day dermal toxicity

90-day inhalation toxicity

N/A - Bifenthrin

Chemical # and Name: 128825

Bifenthrin

12-Jan-2012

GENERIC

ID # GDCI-128825-902

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

TEP

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

12

12

12

24

12

8

24

24

Page 3 of 

(40)

(8)

(18)

(17)

(21, 35)

(10)

(10, 31)

N

N

N

N

Y

N

Y

Y

5
OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

 

Toxicology Data Requirements (Conventional Chemical)

870.7800

860.1500

860.1500

860.1500

860.1500

860.1500

860.1500

860.1500

Immunotoxicity

Crop field trials (HOP, DRIED CONES) 

Crop field trials (ARTICHOKE, GLOBE) 

Crop field trials (COTTON, GIN BYPRODUCTS) 

Crop field trials (HERB, FRESH, SUBGROUP 19A) 

Crop field trials (GRAPE) 

Crop field trials (HERB, DRIED, SUBGROUP 19A) 

Crop field trials (CANEBERRY SUBGROUP 13A) 

N/A - Bifenthrin

Chemical # and Name: 128825

Bifenthrin

12-Jan-2012

GENERIC

ID # GDCI-128825-902

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

TGAI

TEP

TEP

TEP

TEP

TEP

TEP

TEP

12

24

24

24

24

24

24

24

Page 4 of 

(35)

(5, 26)

(5, 27)

(5, 30)

(5, 28)

(4, 5)

(5, 29)

(5, 25)

Y

N

N

N

N

N

N

N

5
Date

OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

 

SS-1065

SS-1066

SS-1069

SS-1072

SS-1099

POTW Treatability Study

Chronic Sediment - Hyalella Azteca

Chronic Sediment - Chironomus dilutus

Chronic Sediment - Leptocheirus plumulosus

Leachability from treated wood

N/A - Bifenthrin

Chemical # and Name: 128825

Bifenthrin

12-Jan-2012

GENERIC

ID # GDCI-128825-902

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

M,A,EE,O,K,R,C,T,B,Q

TGAI

TGAI

TGAI

TGAI

TEP

24

12

12

12

24

Page 5 of 

(6, 34, 35)

(3, 6, 35)

(2, 6, 35)

(1, 6, 35)

(24)

Y

Y

Y

Y

N

5
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Bifenthrin

GDCI-128825-902

1

2

3

4

5

6

7

8

9

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

Use USEPA 2001 Method for Assessing the Chronic Toxicity of Marine and Estuarine Sediment-associated Contaminants with the Amphipod Leptocheirus plumulosus EPA 600/R-0l/020.

Use Test Method 100.5: Life-cycle Test for Measuring the Effects of Sediment-associated Contaminants on Chironomus dilutus (formerly known as C. tentans) in USEPA 2000 Methods for 

Measuring the Toxicity and Bioaccumulation of Sediment-associated Contaminants with Freshwater Invertebrates EPA 600/R-99/064.

Use Test Method 100.4: Hyalella azteca 42-d Test for Measuring the Effects of Sediment-associated Contaminants on Survival, Growth, and Reproduction in USEPA 2000 Methods for Measuring

the Toxicity and Bioaccumulation of Sediment-associated Contaminants with Freshwater Invertebrates EPA 600/R-99/064.

Three field trials are required for grapes in order to fulfill geophraphic representation requirements.

The required test substance is a TEP.

The required test substance is TGAI.

The registrant is required to monitor the volatiles during this study.

The preferred test species is Americamysis bahia.

The environmental chemistry methods should include the parent, bifenthrin, and those residues found in the laboratory studies that exceeded 10% of the applied. The registrant is encouraged to

submit state-of-the-art environmental chemistry methods; further, multi-residue methods are preferred for soil, water, and sediment, if applicable.

Case # and Name:

DCI Number:

Page: 1 of

Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. 

These footnotes apply in addition to any test notes included in 40 CFR Part 158 with respect to the particular data requirement.

Use Categories Key:

A - Terrestrial food crop

B - Terrestrial feed crop

C - Terrestrial nonfood crop

K - Residential

M - Indoor nonfood use

O - Residential Indoor use

Q - Residential outdoor use

R - Agricultural premises and equipment

T - Commercial, institutional and industrial premises

and equipment

EE - Indoor use

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Bifenthrin

GDCI-128825-902

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

Submit protocol for Agency review and approval before beginning study.

Studies performed in 3 soils are required. Data were previously submitted for one soil, but per OPPTS Guideline 835.4200, data are required for a total of four soils. The registrant must monitor 

the volatiles during this study.

Refer to public draft guideline 850.4250 for guidance on Tier II vegetative vigor testing.

Refer to public draft guideline 850.4225 for guidance on Tier II seedling emergence testing.

Only the environmental chemistry methods and independent laboratory validation in soil portion of this guideline is required. Environmental chemistry methods used to generate data associated 

with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available 

as addenda to the guideline for this requirement.

Only the environmental chemistry methods and independent laboratory validation - in water and sediment portion of this guideline are required. Environmental chemistry methods used to 

generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory

validation are available as addenda to the guideline for this requirement.

For developing the required protocol, see OPPTS draft guideline 850.1020 which includes procedures more appropriate for the testing of the hyalella azteca species.

Fish lifecycle toxicity data are required for an estuarine/marine OR freshwater species. However, should the registrant choose to conduct this study on the estuarine/marine species 

(sheepshead minnow), then the requirement for a fish early life stage study (Guideline 850.1400) with an estuarine/marine fish could be satisfied with an acceptable fish lifecycle toxicity study.

Fish early-life stage toxicity data are required for an estuarine / marine species (sheepshead minnow).

Data are required for test species Hyalella azteca to water column exposure, not sediment spiked. Hyalella azteca are a more sensitive species to pyrethroids than the commonly tested 

freshwater invertebrate, Daphnia magna.

Data are required for six species of dicots from at least four families, one species of which is soybean (Glycine max). Data are required for four species of monocots from at least two families,

one species which is corn (Zea mays). At least one of either the monocot or dicot species must be a root crop.

Data are required for a passerine species.

Data are required for a freshwater green alga species, a freshwater diatom species, a marine diatom species, and a cyanobacterium (formerly known as blue-green algae).

Data are required for a duckweed species.

Data are currently in Agency review. When available, EPA will provide the registrant with a Data Evaluation Record documenting its review and classification of the data. Should the Agency 

determine these data to be unacceptable, the leachability from treated wood data requirement will remain outstanding, and new data will be required.

Crop field trials for use of the 25% EC formulation on the caneberry sugroup 13-07A representative commodities blueberry and either blackberry or raspberry are required.

Crop field trials for use of the 25% EC formulation on hops are required.

Crop field trials for use of the 25% EC formulation on artichoke are required.

Crop field trials are required for herb subgroup 19A, fresh whose representative commodities are basil, fresh and chives, fresh. Field trials using an appropriate and practical pre-shipment 

interval are required.

Crop field trials are required for herb subgroup 19A, dried whose representative commodities are basil, dried and chives, dried. Field trials using an appropriate and practical pre-shipment 

interval are required.

Case # and Name:

DCI Number:

Page: 2 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Bifenthrin

GDCI-128825-902

30

31

32

33

34

35

36

37

38

39

40

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

Cotton gin byproduct crop field trials are required to evaluate residue levels and, if necessary, to evaluate the dietary burden to livestock.

An acceptable 28-day study duration should satisfy the Agency's short- and intermediate-term inhalation exposure data needs for this chemical based on current use patterns.

A study performed in one additional soil is required. Data were previously submitted for three soils, but per OPPTS Guideline 835.4100, data are required for a total of four soils. The registrant 

must monitor the volatiles in this study, since that was not done in any of the available studies, and there is uncertainty as to their relevance.

A revised version of method P-2763 is required and will be evaluated to establish if it meets the requirements for tolerance enforcement in walnuts.

A publicly owned treatment works (POTW) treatability study is required for bifenthrin as a bench scale study of wastewater treatment, to assess the percentage of bifenthrin removed in the 

biosolids by treatment, the amount that would degrade during treatment, and the amount that would reamin in the wastewater effluent stream. These data will be used to inform removal 

percentages by wastewater treatment.

A protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.

A protocol must be submitted to the Agency for reivew and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 days or receipt of this DCI.

A new study is required. The Agency may waive the requirement of a cosolvent concentration of less than or equal to 1% by volume provided that the registrant submits the following: 1) The 

UV/Vis spectrum for bifenthin in buffered solution (preferred at pH 5). This will allow the Agency to determine bifenthrin's potential for aqueous photolysis. 2) Information confirming the efforts 

have been made to improve the analytical methods for the parent and possible transformation products. 3) Evidence that acetonitrile (or the cosolvent chosen) does not sensitize bifenthrin, 

causing the rate of photolysis to increase. 4) Proof that the lowest feasible concentration of the cosolvent was used.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC50 

(concentration at which there is a 50% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that bifenthrin "may affect" and is "likely to adversely affect" listed plant 

species.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC25 

(concentration at which there is a 25% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that bifenthrin "may affect" and is "likely to adversely affect" listed plant 

species.

A TEP is the required test substance.

Case # and Name:

DCI Number:

Page: 3 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Bifenthrin

Page: 1 of 1

11678

70506

83520

5481

66330

MAKHTESHIM CHEMICAL WORKS LTD.

UNITED PHOSPHORUS, INC

TACOMA AG, LLC

AMVAC CHEMICAL CORPORATION

ARYSTA LIFESCIENCE NORTH AMERICA, 

LLC 

Co. Nr. Company Name Agent For Company

MAKHTESIM-AGAN OF NORTH 

AMERICA, INC.

BIOLOGIC, INC.

3120 HIGHWOODS BLVD., SUITE 100

630 FREEDOM BUSINESS CENTER, SUITE 402

115 OBTUSE HILL ROAD

4695 MACARTHUR COURT, SUITE 1200

15401 WESTON PARKWAY, SUITE 150

Address City ZIP

RALEIGH

KING OF PRUSSIA

BROOKFIELD

NEWPORT BEACH

CARY

27604 

19406 

06804 

926601706

27513 

OMB Approval 2070-0174

State

NC

PA

CT

CA

NC

 DCI Number: GDCI-128825-902
LINKS TO FORMS:

The pesticide registration forms that are listed below can be found at:

http://www.epa.gov/opprd001/forms/

Link to Confidential Statement of Formula and Instructions (Form # 8570-4)

http://www.epa.gov/opprd001/forms/8570-4.pdf

Certification of Attempt to Enter Into an Agreement With Registrants for 

Development of Data (Form # 8570-32)

http://www.epa.gov/opprd001/forms/8570-32.pdf

Certification With Respect to Citation of Data (Form # 8570-34)

http://www.epa.gov/opprd001/forms/8570-34.pdf